Topic:
Regulatory
Latest Headlines
Latest Headlines
Sequester cuts threaten FDA's access to industry user fees
According to AdvaMed, the user fees that industry players contribute to the FDA, money that currently helps the agency retain staff and support programs, may now take a hit to the tune of about $2.9 million.
Supreme Court takes up Medtronic, Boston Scientific patent spat
The lengthy patent dispute between Medtronic and Boston Scientific will end in the nation's highest courtroom, as the Supreme Court has agreed to hear Medtronic's plea to avoid paying cardiac device royalties.
Covidien O2 saturation measurement devices win FDA's 510(k)
Covidien nailed down a 510(k) clearance, this time for a group of next-generation Nellcor pulse oximetry monitoring devices--a regulatory win that will likely help fuel continued robust growth in the line.
Medtronic wins CE mark for clot-removal tech
Medtronic snagged a CE mark for the Export Advance aspiration catheter, planning to launch the clot-removing device in Europe and other international markets.
FDA slaps 'deadly' label on Abbott's glucose meter recall
In April, Abbott Laboratories announced it was yanking the FreeStyle InsuLinx blood glucose meters off the U.S. market, and now the FDA has assigned its most-serious Class I label to the effort, warning that the devices' malfunction could lead to serious injury or death.
FDA: Merck's sleep drug suvorexant effective, but safety issues draw heavy flak
FDA staffers found clear evidence to prove that Merck's blockbuster drug candidate suvorexant is quite effective in promoting sleep, but the internal review cites multiple safety issues for the high doses studied in clinical trials.
Vascular Solutions sues Boston Scientific for 'blatant' patent infringement
Vascular Solutions is suing Boston Scientific, claiming the company's Guidezilla extension catheter infringes on its patents and asking a Minnesota court to hault the device's sale.
Thoratec wins FDA nod for HeartMate controller
Thoratec scored the FDA's blessing to market a next-generation controller for the HeartMate II implant, giving the company a user-friendly face for its market-leading left ventricular assist device.
EMA says Bayer's Diane-35 has more benefit than risk
France drug regulator in January yanked Bayer's contraceptive Diane-35 off the market and insisted the European Medicines Agency investigate its off-label use as an acne treatment and its risks of blood clots. The EMA has done that and has come down in support of the drug, even for the off-label use.
Shorter Tryton side branch stent wins CE mark
Tryton Medical won a CE mark for a short version of its Side Branch Stent to treat bifurcated lesions, a crucial step toward reaching more patients and pursuing the company's U.S. approval pathway.
